The Recall Desk
SevereFDA (Drugs)·D-0211-2020·Announced 2019-11-13

Red Mountain Compounding Pharmacy Recalls S-Dexpantenol Injection Vials

Red Mountain Compounding Pharmacy is recalling S-Dexpantenol injection vials due to a lack of assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant hazard like lack of sterility in an injectable drug corresponds to a Severe severity score.

Plain-English summary

First Royal Care Co. LLC, doing business as Red Mountain Compounding Pharmacy, is recalling S-Dexpantenol 250mg/ml multi-dose vial injection solution. The recall involves 37 30ml glass vials distributed nationwide in the USA.

The recall was initiated due to a lack of assurance of sterility. The affected lots include S03072019DH@08, S02142019DH@08, S03072019DH@07, 03072019DH@08, S03042019DH@07, S04172019DT@02, S05232019DT@10, S06242019DH@10, S07172019DT@07, and S07242019DH@09.

Consumers should check their medication for these specific lot numbers and expiration dates. If the product matches the recalled items, they should contact their healthcare provider or the pharmacy for instructions on disposal or replacement.

The recalled product

Product
S-DEXPANTHENOL 250MG/ML MDV INJ SOLN, 30ML glass vials, RX Only, Red Mountain Compounding RX

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (19)

  • Lot #: S03072019DH@08
  • Exp 9/7/19
  • S02142019DH@08
  • Exp 8/14/19
  • S03072019DH@07
  • 03072019DH@08
  • 9/7/19
  • S03042019DH@07
  • Exp 9/4/19
  • S04172019DT@02
  • Exp 10/17/19
  • S05232019DT@10
  • Exp 11/23/19
  • S06242019DH@10
  • Exp 12/24/19
  • S07172019DT@07
  • Exp 1/17/20
  • S07242019DH@09
  • Exp 1/24/20

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 100 recalled by First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 100 products in this recall →

Same manufacturer · First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

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